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Test Code NASHFIBRO NASH FibroSure®

Important Note

Please indicate patients height and weight on the test request

Performing Laboratory

LabCorp at Burlington, NC

Specimen Required

Container/Tube:  Red or Gold top tube

Specimen: 3.5 mL serum ( 2 mL min)

Transport Temperature: Refrigerated  (for 72 hrs) or Frozen (for 7 Days)

 

Note: Patient should be fasting for at least eight hours

  Please indicate patients height and weight on the test request.

 

Reference Values

See Report

Test Classification and CPT Coding

82172; 82247; 82465; 82945; 82977; 83010;

83883;  84450;  84460;  84478

Computer Interface Code

PDM # 1559233

Useful For

This test is a noninvasive assessment of liver status in patients with nonalcoholic fatty liver disease (NAFLD). Quantitative results of 10 biochemicals in combination with age, gender, height, and weight are analyzed using a computational algorithm to provide a quantitative surrogate marker (0.0-1.0) of liver fibrosis (Metavir F0-F4), hepatic steatosis (0.0-1.0, S0-S3), and nonalcoholic steatohepatitis (NASH) (0.0-0.75, N0-N2). The absence of steatosis (S<0.38) precludes the diagnosis of NASH.

 

 

Limitations

NASH FibroSure® is recommended for patients with suspected nonalcoholic fatty liver disease. It is not recommended for patient with other liver diseases. It is also not recommended in patients with Gilbert disease, acute hemolysis, acute hepatitis, acute inflammation of the liver, autoimmune hepatitis, extrahepatic cholestasis, transplant patients, and/or renal insufficiency patients. Any of these clinical situations may lead to inaccurate quantitative predictions of fibrosis.

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.